(70 days)
Hand-held IPL device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The IPL Home Use Hair Removal Device is composed of a hand-held applicator and an external power supply. The spot size (treatment area) in the IPL Home Use Hair Removal Device is 3cm². The device contains a lamp, a skin proximity sensor. If the IPL Home Use Hair Removal Device is not properly applied (in full contact with the skin), the device will not trigger a pulse.
The IPL Home Use Hair Removal Device includes FZ-608, FZ-608G, FZ-100, and FZ-200 four models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance, energy output range and its equipped power supply model. The model difference is embodied in: #1) energy output level of model FZ-608 and FZ-608G has 9 levels, corresponding to an output range of 4.16J10J; model FZ-100 has 9 levels, corresponding to an output range of 5.7J16.26J, and model FZ-200 has 6 levels, corresponding to an output range of 4.6J~13,5J; #2) the main unit FZ-608 and FZ-608G can be supplied by the power adaptor (model: SHCSP2402000FUS), and the main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.
The provided document is a 510(k) summary for an IPL Home Use Hair Removal Device (K230739). It outlines the device's substantial equivalence to predicate devices, focusing on safety and efficacy for over-the-counter (OTC) use.
However, the document does not contain information related to an AI/algorithm-driven device or a study involving ground truth, expert consensus, MRMC studies, or training/test sets for AI models. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the regulatory requirements for a medical device's safety and effectiveness for its intended use, not an AI algorithm's performance against specific metrics established by expert review.
The performance testing mentioned is for the physical device itself (electrical safety, EMC, biocompatibility, and usability/self-selection for OTC use), not for an AI's diagnostic or analytical capabilities.
Therefore, I cannot populate the requested table and answer the specific questions about AI acceptance criteria, ground truth, expert adjudication, or MRMC studies for this device based on the provided text.
The relevant "study" mentioned in the document is a usability study for OTC use, not an AI performance study.
Here's a breakdown of what is available in the document regarding the device's acceptance and testing:
Device Acceptance Criteria and Performance (Based on Usability Study for OTC Use)
The document states that a usability study was conducted to demonstrate that the device is safe and effective for over-the-counter (OTC) use by lay users. The "acceptance criteria" here are implied regulatory requirements for OTC medical devices, specifically regarding user comprehension and safe application.
| Acceptance Criterion (Regulatory Implication for OTC Device) | Reported Device Performance (from Usability Testing) |
|---|---|
| Self-selection: Lay users can determine if they are appropriate candidates for the device based on external labeling. | The study demonstrated that "the lay user can self-select themselves as being appropriate users of this device by the external box labeling." |
| Safe and Correct Application: Lay users can apply the treatment safely and correctly following the instructions for use. | The study demonstrated that "the lay user can apply the treatment safely and correctly according to the instructions for use." |
| Comprehension of Labeling: Lay users understand indications, contraindications, warnings, and precautions, and can identify if they are in a contraindicated group. | The study demonstrated that "the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual." |
Detailed Information Not Applicable to an AI Study:
Since this is a physical medical device (IPL hair removal) and not an AI/algorithm, the following points outlined in your request are not addressed or are not relevant in the provided text:
- Sample size for the test set and data provenance:
- Test set sample size: 24 subjects (for the usability/OTC study).
- Data provenance: Not explicitly stated, but likely prospective given it's a usability study involving direct interaction with subjects. Country of origin not specified, but the applicant company is Shenzhen, China.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for an IPL device's usability doesn't involve expert medical image review.
- Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert review settings (e.g., radiology). For a usability study, the "adjudication" would be whether users successfully completed tasks or understood information.
- MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone (algorithm only) performance: Not applicable. There is no AI algorithm.
- Type of ground truth used: For the usability study, the "ground truth" would be the successful demonstration of user comprehension and safe device operation, assessed by usability researchers, not medical experts interpreting data like pathology or outcomes.
- Sample size for the training set: Not applicable. There is no AI model to train.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device. While it includes "performance testing," this refers to electrical safety, biocompatibility, and OTC usability, not the performance of an AI algorithm against clinical ground truth.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.